Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 248-765-1 | CAS number: 27987-25-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 16 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 19.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The oral rat NOAEL is converted to an inhalatory rat NOAEC by using a default respiratory volume for the rat corresponding to 8 h exposure, which is the relevant duration of worker exposure (0.38 m³/kg bw) and by application of a factor of 2 for route to route extrapolation. The resulting rat inhalatory NOAEC is converted into inhalatory worker NOAEC by correction for respiratory rate based on activity (6.7 m³ for normal light activity versus 10 m³ for worker activity) and by correction for 5 day exposure (7 days versus 5 days): 16 * (1/0.38) * (1/2) * (6.7/10) * (7/5) = 19.7 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 5
- Justification:
- default factor for worker
- AF for the quality of the whole database:
- 1
- Justification:
- guideline stuy
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 16 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 22.4 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As explained in the endpoint summary on toxicokinetics, metabolism and distribution, dermal absorption is likely low. But since it might be enhanced because of the irritating properties of the test substance, and no explicit value can be stated, the same absorbtion is assumed after dermal and oral exposure. The NOAEL has been corrected for a working week of 5 days (factor 7/5): 16 * (7/5) = 22.4 mg/kg bw/d.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor rat => human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.28 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 16 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The oral rat NOAEL is converted into an inhalatory rat NOAEC by using a default respiratory volume for the rat corresponding to 24 h exposure, which is the relevant duration for general population, (1.15 m3/kg bw) and by application of a factor of 2 for route to route extrapolation: 16 * (1/2) * (1/1.15) = 7.0 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required for inhalation
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no remainnig uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 16 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 16 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As explained in the endpoint summary on toxicokinetics, metabolism and distribution, dermal absorption is likely low. But since it might be enhanced because of the irritating properties of the test substance, and no explicit value can be stated, the same absorbtion is assumed after dermal and oral exposure. No adaptation of the NOAEL has thus been performed.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor rat => human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.16 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 16 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL available
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on developmental effects in males in a 2-generation reproductive toxicity study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default factor rat => human
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- default
- AF for the quality of the whole database:
- 1
- Justification:
- guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- no further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Consumer DNELs have been derived to assess man via environment only. No consumer uses are foreseen for this substance.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
